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Please note that the OMB number and expiration date may not have been determined when this Information Collection Request and associated Information Collection forms were submitted to OMB. The approved OMB number and expiration date may be found by clicking on the Notice of Action link below.
View ICR - OIRA Conclusion
OMB Control No:
0910-0660
ICR Reference No:
200908-0910-004
Status:
Historical Active
Previous ICR Reference No:
Agency/Subagency:
HHS/FDA
Agency Tracking No:
Title:
Prevention of Salmonella Enteritidis in Shell Eggs During Production---Recordkeeping and Registration Provisions
Type of Information Collection:
New collection (Request for a new OMB Control Number)
Common Form ICR:
No
Type of Review Request:
Regular
OIRA Conclusion Action:
Approved with change
Conclusion Date:
05/06/2010
Retrieve Notice of Action (NOA)
Date Received in OIRA:
08/10/2009
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
05/31/2013
36 Months From Approved
Responses
805,796
0
0
Time Burden (Hours)
406,750
0
0
Cost Burden (Dollars)
0
0
0
Abstract:
Shell eggs contaminated with Salmonella Enteritidis (SE) are responsible for more than 140,000 illnesses per year. The Food and Drug Administration (FDA) is requiring each farm site with 3,000 or more egg laying hens that sells raw shell eggs to the table egg market, other than directly to the consumer, and does not have all of the shell eggs treated, to design and monitor an SE prevention plan. In addition, all farms covered by any part of the rule are required to register with FDA. We have concluded that recordkeeping and registration are necessary for the success of the SE prevention measures. Written SE prevention plans and records of actions taken due to each provision are essential for farms to implement SE prevention plans effectively. Further, they are essential for FDA to be able to determine compliance. The Public Health Service Act (PHS Act) authorizes the Secretary to make and enforce such regulations as "are necessary to prevent the introduction, transmission, or spread of communicable diseases from foreign countries into the States * * * or from one State * * * into any other State" (section 361(a) of the PHS Act). This authority has been delegated to the Commissioner of Food and Drugs. Under section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 342(a)(4)), a food is adulterated if it is prepared, packed, or held under insanitary conditions whereby it may have been contaminated with filth or rendered injurious to health. Under section 701(a) of the act (21 U.S.C. 371(a)), FDA is authorized to issue regulations for the efficient enforcement of the act.
Authorizing Statute(s):
US Code:
21 USC 342
Name of Law: FFDCA
US Code:
21 USC 371
Name of Law: FFDCA
Citations for New Statutory Requirements:
US Code: 21 USC 371 Name of Law: FFDCA
Associated Rulemaking Information
RIN:
Stage of Rulemaking:
Federal Register Citation:
Date:
0910-AC14
Final or interim final rulemaking
74 FR 33030
07/09/2009
Federal Register Notices & Comments
Did the Agency receive public comments on this ICR?
Yes
Number of Information Collection (IC) in this ICR:
11
IC Title
Form No.
Form Name
Chick and Pullet Procurement Records
Cleaning and Disinfection Records
Egg Testing
Environmental Testing
Prevention Plan Design
Prevention Plan Review and Modification
Refrigeration Records
Reporting Producer Registration
FDA - 3733
DHHS/FDA SHELL EGG PRODUCER REGISTRATION
Rodent and Other Pest Control and Biosecurity Records
Testing, Diversion or Treatment (Positive)
Testing, Diversion, amd Treatment (Negative)
ICR Summary of Burden
Total Approved
Previously Approved
Change Due to New Statute
Change Due to Agency Discretion
Change Due to Adjustment in Estimate
Change Due to Potential Violation of the PRA
Annual Number of Responses
805,796
0
0
805,796
0
0
Annual Time Burden (Hours)
406,750
0
0
406,750
0
0
Annual Cost Burden (Dollars)
0
0
0
0
0
0
Burden increases because of Program Change due to Agency Discretion:
Yes
Burden Increase Due to:
Changing Regulations
Burden decreases because of Program Change due to Agency Discretion:
No
Burden Reduction Due to:
Short Statement:
This is a new collection requirement. The increase in reporting and recordkeeping burdens reflect our estimate of the number of registrations that would be required by the final rule and the amount of recordkeeping associated with the SE prevention plans required by the final rule.
Annual Cost to Federal Government:
$116,615
Does this IC contain surveys, censuses, or employ statistical methods?
No
Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002?
No
Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]?
Uncollected
Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]?
Uncollected
Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)?
No
Is this ICR related to the Pandemic Response?
Uncollected
Agency Contact:
Jonnalynn Capezzuto 3018274659
Common Form ICR:
No
On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).
The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:
(a) It is necessary for the proper performance of agency functions;
(b) It avoids unnecessary duplication;
(c) It reduces burden on small entities;
(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;
(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;
(f) It indicates the retention periods for recordkeeping requirements;
(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:
(i) Why the information is being collected;
(ii) Use of information;
(iii) Burden estimate;
(iv) Nature of response (voluntary, required for a benefit, or mandatory);
(v) Nature and extent of confidentiality; and
(vi) Need to display currently valid OMB control number;
(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.
(i) It uses effective and efficient statistical survey methodology (if applicable); and
(j) It makes appropriate use of information technology.
If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.
Certification Date:
08/10/2009
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